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Monday, November 24, 2014         

NEW YORK TIMES


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Medical experiments conducted on alcoholics in 1950s

By Gina Kolata

New York Times

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NEW YORK » A medical researcher from Columbia University, Dr. Perry Hudson, made the skid row alcoholics in lower Manhattan an offer: If they agreed to surgical biopsies of their prostates, they would get a clean bed and three square meals for a few days, plus free medical care and treatment if they had prostate cancer.

It was the 1950s, and Hudson was trying to prove that prostate cancer could be caught early and cured. But he did not warn the men he was recruiting that the biopsies to search for cancer could cause impotence and rectal tears. Or that the treatment should cancer be found — surgery to remove their prostates and, often, their testicles — had not been proven to prolong life. But he said in a recent telephone interview that he believed the treatments did prolong life. "I told them the cure rate is extremely high," he said.

As more than 1,200 men living in flophouses on the Bowery signed up for Hudson's study in the 1950s and '60s, neither his academic peers nor the federal officials overseeing his grants criticized his ethics, but times have changed. Two papers published Thursday in the American Journal of Public Health and the Bulletin of the History of Medicine prompted medical historians to denounce this largely forgotten chapter in the history of government-financed medical research on vulnerable populations.

They said the Bowery study was unethical because of the powerlessness of the people who participated in it and of the things done to them.

"The invasiveness of this particular research was really horrendous," said Alan Brandt, a Harvard medical historian who has written about the Tuskegee experiment, in which hundreds of poor black men with syphilis were left untreated to observe the natural course of the disease, a study that began in 1932 and was not halted by the U.S. Public Health Service until 1972.

Dr. Robert Aronowitz, an internist and medical historian who wrote the new papers, stumbled upon the Bowery study — which was led by Hudson, a urologist trained at Johns Hopkins, and paid for by the National Institutes of Health, among others — and was so troubled by it that he became consumed with documenting what had happened.

"Hudson used Bowery men because only desperate, poor, and unknowing men would participate," Aronowitz wrote. "It was unimaginable that the average American man would volunteer."

Hudson's colleagues did not question his use of down-and-out men with alcoholism, some of them mentally ill, or his failure to inform them carefully about the potential risks of his research, said William Parry, a urologist at the University of Rochester at the time.

In the 1950s, prostate cancer was usually discovered late after it had spread and was almost always fatal.

"It was an entirely different era," said Parry, now 89 and an emeritus professor at the University of Oklahoma.

In fact, as Hudson pursued his research, his work was widely cited in urological journals and textbooks and admiringly featured in a 1957 photography spread in Life magazine.

Aronowitz cites a popular history, "The Bowery Man," published in 1961, in which the author, Elmer Bendiner, reported that staff members at a city-run lodging house where study participants stayed helped Hudson ensure their participation.

"Once a man chosen for the study was persuaded to volunteer, the authorities lifted his meal ticket and returned it only when he had kept his appointment," Bendiner wrote.

Hudson himself makes no apologies for recruiting impoverished alcoholics. Now 96 and living in South Pasadena, Fla., he said in recent interviews that the men volunteered, that they were not paid and that they got "the best care in New York."

Doctors in private practice would never have allowed their patients to get biopsies since they assumed that the disease was fatal, he said.

Hudson was 33 and had just taken a position as head of urology at the Francis Delafield Hospital, a public cancer hospital in New York, when he and his colleagues began recruiting homeless men in 1951. He got the idea of going to the Bowery when he was caring for a man who had been a Princeton history professor but ended up a homeless alcoholic living there.

At first, Hudson said, the Bowery men resisted his offers. He recalled speaking at one of the flophouses just before bedtime. "I had a lot of old vegetables thrown at me," he said. "I was talking about making a small incision in a very interesting part of their anatomy." But many eventually agreed to participate.

Unlike modern prostate biopsies, which involve the use of a thin needle, the biopsies done in the Bowery study involved cutting a small slice out of the men's prostates. Hudson said he told the men they might get a local infection from the biopsy, but a man who worked as a urology resident on the project told Aronowitz that he saw many other complications in the Bowery men.

Aronowitz got the approval of his university's ethics committee to speak to the former resident, who had just read "The Immortal Life of Henrietta Lacks," the best-selling book about a black woman whose cancer cells were cultured without her permission in 1951.

Worried about the ethics of the Bowery study, the former resident declined to be named in the paper, but told Aronowitz in a recorded interview that the biggest fear among the doctors doing the biopsies was that they would cause rectal perforations, and he regretted not telling the men in writing about that risk.

Aware of Hudson's contention that the biopsy would not cause serious injuries, two urologists published case reports in 1957 on the experiences of 24 men who had biopsies that found no cancer. Many of them had serious complications, including rectal lacerations. A third of them became impotent and another third had diminished sexual function.

About 100 of the men who participated in the Bowery study were found to have cancer and aggressively treated for it with surgery and, for many, estrogen - a combination of therapies that was far from the standard of care at the time.

The men had their prostates removed and faced likely impotence and incontinence. And those who were also surgically castrated and given a powerful estrogen had well-known side effects from these treatments. Having their testicles removed caused a loss of sexual desire, muscle tone and stamina, and estrogen caused a heightened risk for heart attacks and strokes.

Parry said that a later study found that estrogen therapy offered no advantages over a placebo in prolonging life in patients with prostate cancer.

"The fact that these people, a convenient population, were used in the name of science is abhorrent," said Jason Schwartz, a historian of medicine who served on a presidential commission that investigated human experiments in which prisoners and mental patients in Guatemala were intentionally infected with syphilis in the 1940s to test penicillin.

Those experiments were approved by the highest medical officials in the U.S. government. In 2010, President Barack Obama apologized to the president of Guatemala for the experiments.

Although the Bowery study had a laudable goal — to prove that prostate cancer could be caught early and cured — it yielded little credible data.

Hudson did not set up a control group of Bowery men who did not get the biopsies and treatment. As a result, he had no way of comparing the men who got the interventions with those who did not or of documenting whether the men he treated lived longer.

But Aronowitz cautions that people today should not feel an easy moral superiority to those who worked on the Bowery study. Millions of American men now get screened for prostate cancer every year, and more than 200,000 of them get biopsies. Tens of thousands have their prostates removed because the biopsies showed cancer cells, even though the men showed no symptoms of cancer.

"As the efficacy of the screen-and-treat paradigm was never established, the practices of the past few decades can be understood as a mass experiment conducted on ill-informed men," he wrote.

A federal panel of experts recommended in 2011 that men no longer get the PSA blood test to screen for prostate cancer because clinical trials had found that the test's benefits were uncertain and its risks — treatments that needlessly cause incontinence and impotence — were severe.

But many urologists believe that screening saves lives, and the American Urological Association recommends that men consider starting it at age 55.

"Ethical tragedies are difficult to recognize in the present," Aronowitz wrote. "Future observers may view the massive evidence-based expansion of our screen-and-treat paradigm in prostate cancer in the same way as we now view the Bowery series practices."






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